Real-life Clinical Outcomes of Direct Oral Anticoagulants (MACACOD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-29

Study Completion Date

2024-08-31

Brief Summary

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MACACOD is a clinical record in the usual clinical practice of direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban). Design: single-center, observational, prospective, uncontrolled study of anticoagulated patients with any direct oral anticoagulant (DOAC) with atrial fibrillation or venous thromboembolism to determine the incidence of serious complications (thromboembolic or hemorrhagic) in real life

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Detailed Description

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Population: Patients over 18 years of age, with recurrent atrial fibrillation or venous thromboembolism, already anticoagulated with any DOAC or patients who initiate therapy with DOAC and who give their consent. Upon entering the study, demographic data, previous anticoagulant treatments, previous serious complications, comorbidities and baseline analytical results are recorded. The risk scores CHA2DS2-Vasc, HAS-BLED and Charlson comorbidity index (CCI) are calculated. The type of health education received in relation to anticoagulant therapy is also recorded. During the follow-up, complications and clinical changes and the analytical results of coagulation, renal and hepatic function will be recorded. The risk scores will be updated at each visit. In case of serious complications, the associated costs will be estimated.

Conditions

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Atrial Fibrillation Recurrent Venous Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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dabigatran, rivaroxaban, apixaban or edoxaban

Record of all serious complications associated with any of the drugs and the clinical changes that occurred during prospective follow-up.

Intervention Type DRUG

Other Intervention Names

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Pradaxa, Xarelto, Eliquis or Lixiana

Eligibility Criteria

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Inclusion Criteria

· Patients older than 18 years.

* With atrial fibrillation or recurrent venous thrombosis.
* In chronic treatment with any DOAC type drug.
* Patients who sign the informed consent

Exclusion Criteria

* Patients who do not guarantee collaboration.
* Patients with advanced cognitive impairment and not supervised.
* Patients with alcoholism.
* Patients with psychiatric disorder and not supervised

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No